Thrombolysis device

ABSTRACT

The present invention describes a catheter suitable for introduction into a tubular tissue for dissolving blockages in such tissue. The catheter is particularly useful for removing thrombi within blood vessels. In accordance with the preferred embodiments, a combination of vibrating motion and injection of a lysing agent is utilized to break up blockages in vessels. The vessels may be veins, arteries, ducts, intestines, or any lumen within the body that may become blocked from the material that flows through it. As a particular example, dissolution of vascular thrombi facilitated by advancing a catheter through the occluded vessel, the catheter causing a vibrating, stirring action in and around the thrombus usually in combination with the dispensing of a thrombolytic agent such as urokinase into the thrombus. The catheter has an inflatable or expandable member near the distal tip which, when inflated or expanded, prevents the passage of dislodged thrombus around the catheter. The dislodged portions of thrombus are directed through a perfusion channel in the catheter, where they are removed by filtration means housed within the perfusion channel before the blood exists the tip of the catheter. Catheters that allow both low frequency (1-100 Hz) vibratory motion and delivery of such agents to a blockage and a method for using such catheters are disclosed.

CROSS-REFERENCES TO RELATED APPLICATIONS

The present application is a continuation of application Ser. No.09/005,217, filed on Jan. 9, 1998, now U.S. Pat. No. 6,287,271, whichwas a continuation-in-part of application Ser. No. 08/483,071, filed onJun. 7, 1995, now U.S. Pat. No. 5,713,848, which was acontinuation-in-part of application Ser. No. 08/320,184, filed on Oct.7, 1994, now U.S. Pat. No. 5,498,236, which was a continuation ofapplication Ser. No. 08/065,470, filed on May 19, 1993, now U.S. Pat.No. 5,380,273, which was a continuation-in-part of application Ser. No.07/885,665, filed on May 19, 1992, now abandoned, the full disclosuresof which are incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention is generally directed to removal of blockage oftubular tissue and specifically directed to the dissolution ofintravascular thrombi.

2. Description of the Background Art

It is well known that the formation of thrombi (clots) in blood vesselsis a serious medical malady. Thrombi are correlated to the formation ofplaque buildup in blood vessels and when blockage occurs, it is more aresult of the thrombi than of the plaque buildup (which is usuallyreferred to as atherosclerosis when it is involved in arteries).

All thrombi need not be treated interventionally, but in many instancesthrombi do, in fact, become life threatening and require removal or atleast reduction in size. A thrombus is primarily comprised of red bloodcells and fibrin There are several treatments which could be adapted forthe removal of thrombi in vessels which involve intravascular catheters.Most such intravascular catheters have been designed primarily forplaque removal and contain an element that vibrates at ultrasonicfrequencies. Representative of such atherectomy catheters are U.S. Pat.Nos. 5,069,664, 4,920,954, 4,898,575, and 4,808,153. Some involvecutting the plaque off of the wall of the vessel using a cutting blade.Some may be adapted to facilitate removal of a thrombus in a vessel. Forexample, DonMicheal, et al., in U.S. Pat. No. 4,870,953, describes anintravascular catheter having a bulbous head at its distal end whichvibrates at ultrasonic frequencies. It is suggested that such a tipmight be useful for disintegrating a thrombus. DonMicheal, et al., alsoteaches the discharge of a radiographic contrast medium from thecatheter tip to enable visualization of the cleared vessel. A secondcooling solution may be circulated through the catheter to the tip toprevent overheating of the bulbous tip. All the foregoing intravenouscatheters have their shortcomings. None are particularly adapted forremoving thrombi.

The use of laser catheters for treatment of thrombi is not uncommon, andsignificant damage to vessels during this treatment have been reported.The use of drugs for the primary dissolution of these clots is extremelycommon and is often considered the primary treatment of choice when athrombus is present. These drugs are referred to as thrombolytic agents(meaning clot dissolution or decomposition). The most commonthrombolytic agents (drugs) that are used presently in the treatment ofvascular thrombosis are such agents as urokinase, streptokinase, TPA,leech saliva and other such pharmaceutical clot dissolving agents.Significant problems such as hemorrhagic complications, earlyrethrombosis, prolonged infusion times, costs, significant failurerates, etc., are persistent problems with the use of thesepharmaceutical agents. To overcome the aforesaid problems with drugs, anintravascular spraying catheter may be placed in or near a thrombus andthe clot periodically sprayed (or pulsed) with a thrombolytic agentwhich facilitates clot dissolution. Using intermittent spraying ofthrombolytic agents may enable the use of less drug over a shorter timeperiod to effect for thrombolysis when compared to the more classicalapproach of allowing the drug to drip in or near the clot. But even thisapproach requires excessive time and drug amount. In addition, the useof pulsatile injections of thrombolytic agents may result in pieces ofthe clot fracturing off from the main body of the clot and causing anembolism which is a danger faced by interventionalists performing thisprocedure. It is, therefore, desirable to provide an improved catheterfor delivering thrombolytic agents which reduce the time and amount ofpharmaceutical agent required for thrombolysis and which reduces thedanger of embolism.

Stiles, in U.S. Pat. No. 4,692,139 (incorporated herein by reference),describes a catheter for removing obstructions from biological ductswhich transmits ultrasonic vibrations to the obstruction to facilitatelysis. Stiles' catheter has means for administering a lysing agent andsimultaneously administering ultrasonic vibrations to obstructingmaterial forward of the catheter tip. The Stiles catheter has avibrating probe which probe (when the catheter is deployed within avessel) projects from the tip of the catheter. There is no teaching ofany advantages to be gained by either (a) vibrating the catheter (asopposed to a probe housed within a catheter), or (b) using lowfrequencies (frequencies below 1000 Hz). Further, Stiles teaches the useof vibrational frequencies in the range “of at least 60 KHz.” Thevibrational frequency employed to effect lysis is an important issue. Itis noted that at the frequencies suggested by Stiles' teaching, thewavelength of ultrasound in the probe is$\lambda = {\frac{v}{f} < \frac{1000}{f} < \frac{1000}{60,000}}$

or λ<{fraction (1/60)} foot. Thus, in Stiles' catheter there arenormally many wavelengths of ultrasound between the ultrasonic sourceand the probe tip. Wherever the probe tip touches the surroundingaspiration tube walls and/or aspirate, energy will be lost due toheating. Thus, it is difficult or impossible to control the amount ofultrasonic vibratory energy reaching the tip of the probe. Depending onthe amount of loss of ultrasonic vibrational energy that occurs alongthe length of the probe (which, of course, depends on the amount ofaspirate in the aspirator tube and the amount of mechanical contactbetween the probe and the surrounding walls) the energy actuallydelivered to tissue at the probe tip may either ablate or weld tissue,emulsify an obstruction or be insufficient to have any effect on anobstruction.

Lower frequency vibrations (less than 100 Hz) have wavelengths greaterthan one foot. The amplitude and, therefore, the energy of the lowfrequency vibration delivered to the tip of a catheter is much morepredictable at the lower frequencies and enable more accurate dosimetry.This is because the vibratory loss to surrounding tissue is due touniform frictional losses along the length of the elongate member(inserted catheter). Stiles' probe, which vibrates at ultrasonicfrequencies as noted above, is housed within an aspiration tube where itmay unpredictably be loaded by contact with any aspirate that may bepresent or the surrounding catheter walls. That is, the undesirablecoupling of vibratory energy out of the Stiles' probe is unpredictable.It would be desirable to provide an interventional catheter having astructure wherein the vibrating element contacts the tissue along itsentire length.

All of the prior art thrombolysis catheters have specified ultrasonicfrequencies (above audible frequencies) when advocating adjunctivevibratory waves to assist thrombolysis. Perhaps this is due to theavailability of compact solid state crystals that oscillate or may bedriven at these frequencies. Perhaps it is the belief that thesefrequencies assist in “emulsifying” an obstruction such as a thrombus.Whatever the reason, the present teaching surprisingly shows that theapplication of low frequency mechanical vibrations facilitate thrombusdisintegration. Even more surprisingly, this is true even in the absenceof an exogenous lysing agent.

SUMMARY OF THE INVENTION

While the invention is best understood and taught by making reference tothe invention in context of a particular application such as thetreatment of vascular thrombosis, it is the object of the presentinvention to provide a catheter (herein alternatively referred to as a“motion catheter” or a “vibrating catheter”) that can be placed in ablocked lumen in the body and, by either utilizing the motion of thecatheter alone or the catheter motion in combination with the dispensingof a medicament suitable for dissolving such blockage, dislodge or morepreferably, dissolve said blockage. This motion catheter, which may besimply a moving wire, can be used alone for blockage removal or with alysing agent to dissolve the blockage. Most preferably, both motion anddispensing are used in combination to effect blockage removal.

The objects of this invention are achieved, in general, by providing avibrating wire, or alternatively, a vibrating catheter that has an openlumen for delivery of said lysing agents. The vibrating catheter mayhave one or more directional channels for delivery of a lysing agentwhich channel(s) are attached to a pump so that delivery of said lysingagent can be controlled with respect to delivery time and delivery rateof the lysing agent.

Because blockage of lumens in the body are often times visualized withimage enhancement devices, the catheter of the present invention isconveniently placed by means of fluoroscopy, ultrasound or the like. Themotion catheter may be placed in the body in any tubular tissue inproximity to said blockage so that the motion of the catheter willdislodge or preferably dissolve the blockage.

A specific application of the aforementioned motion catheter is thedissolution of blood clots or thrombi with or without the use of alysing/thrombolytic agent such as urokinase, streptokinase or a similarlysing agent. If the distal tip of the motion catheter is placed injuxtaposition to a blood clot (proximal, distal, inside or adjacent tothe clot), the low frequency (1-5000 Hz) motion of the catheterfacilitates the dislodgment by mechanical agitation of the thrombolyticclot. Dissolution may be achieved if the vibrating catheter alsodispenses a thrombolytic agent. Usually the thrombi are located in anartery. As a thrombus dissolves, it is desirable that the tip of themotion catheter be moved (with regard to its originalplacement/location) to keep the tip in juxtaposition with the clot andto further facilitate the dissolution of the thrombi.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic view of a preferred embodiment of the motioncatheter of the present invention.

FIG. 2 is a cross-sectional view of the distal treatment tip of thecatheter of FIG. 1 along line 2—2.

FIG. 3 is a cross-sectional view of the motion catheter of FIG. 1 takennear the proximal end of the catheter along line 3—3.

FIG. 4 is a longitudinal cross-sectional view of the proximal end of themotion catheter of FIG. 1 taken along line 4—4.

FIG. 5 is a schematic perspective view of the preferred embodiment ofthe motion catheter of the present invention wherein the distaltreatment tip of the catheter of the present invention is embedded inthe obstruction (shown in cross-section) causing blockage of the lumen.

FIG. 6 is a schematic perspective of the preferred embodiment of thepresent invention shown in FIG. 5 wherein the motion catheter passesthrough or around the obstruction and the lysing agent (if required)emanates from the most distal portion of the catheter.

FIG. 7 is a schematic perspective view of the preferred embodiment ofthe present invention shown in FIG. 5 wherein the distal treatment tipof the catheter protrudes through the clot/obstruction and the lysingagent sprays inside the clot and both proximal and distal to the clot.

FIG. 8 is a cross-sectional view of the preferred embodiment of thepresent invention in FIG. 5 wherein the distal treatment tip of themotion catheter is located proximal to the obstruction and the sprayinglysing agent delivered from the tip in a direction parallel to the longaxis of the catheter.

FIG. 9 is a perspective view of the distal tip of the preferredembodiment of the present invention shown in FIG. 5 wherein the motioncatheter is rotating or oscillating in a to-and-fro motion while thelysing agent is being dispensed.

FIG. 10 is a cross-sectional view of the preferred embodiment of thepresent invention shown in FIG. 5 wherein the lysing agent is dispensedby holes in the distal tip and is directed within and/or under the bodyof the obstruction.

FIG. 11 is a cross-sectional view of a second preferred embodiment ofthe present invention wherein an inflatable vessel occluder near thedistal tip of the catheter blocks the flow of blood around the outsideof the catheter thereby forcing the blood to flow through a particlefilter housed within a perfusion channel within the catheter.

FIG. 12 illustrates a prospective view of an aspiration embodiment ofthe present invention.

FIG. 13 illustrates the distal end of an aspiration embodiment of thepresent invention.

FIG. 14 illustrates an alternate embodiment of an aspiration device ofthe present invention.

FIG. 15 illustrates an additional alternative embodiment of anaspiration device of the present invention.

FIG. 16 illustrates the use of a balloon mechanism with the catheter ofthe present invention.

FIGS. 17 through 20 illustrate various embodiments of a filter trap withand without the use of the aspiration device of the present invention.

DESCRIPTION OF THE SPECIFIC EMBODIMENTS

Turning now to FIG. 1, a preferred embodiment of the motion catheter ofthe present invention is generally indicated at the numeral 10. Thecatheter 10 has a proximal end 11 and a distal or treatment end 12. Theproximal end 11 matingly engages a vibrating member 16 which vibratingmember 16 is driven by an oscillator 15. The catheter 10 may have one ormore lumens extending from the proximal end to the distal end. Onelumen, which is optional, is a guidewire lumen which enters the catheterthrough the guidewire lumen port 13 and exits the catheter through thedistal tip 12. A second lumen, having an entry port generally indicatedat 14, extends the length of the catheter to the distal tip 12 and isused as a conduit for transporting a lysing agent or other compatiblefluid (e.g., saline) from a reservoir (not shown) to the distal tip 12of the catheter 10.

The distal tip 12 of the catheter 10, which may be radiopaque, is shownin cross-section in FIG. 2. A lysing agent lumen 21 extends the lengthof the catheter connecting the lysing agent entry port 14 withdispensing holes near the distal tip 12. There may be one or more holessurrounding the tip 12, which holes are in fluid communication with thelysing agent lumen 21. The guidewire lumen 22, which is optional,enables the use of the catheter with a guidewire. The guidewire (notshown) may be introduced into the vessel in which the catheter is to beinserted for removing blockage. The abnormal narrowing or constrictionof a passage or lumen such as results from a clot lodged in a bloodvessel is called a stenosis. The guidewire is advanced, usually by meansof x-ray, until it reaches the point of stenosis. The guidewire may thenbe either forced through the stenosis or it may terminate at thestenosis. The catheter 10, may then be inserted over the guidewire andadvanced so that the distal tip 12 of the catheter is in juxtapositionwith the blockage. While for many applications the presence of aguidewire lumen is necessary, for other applications it is not required.A pump (not shown) may be used to force a lysing agent into the lysingagent lumen 21 through the entrance port 14.

It is known in the prior art to be advantageous to have an elementwithin an intravascular catheter capable of vibration at highfrequencies. Such catheters normally require the element to vibrate atultrasonic frequencies to effect the result desired. Accordingly, suchcatheters employ a titanium wire coupled to an ultrasonic generator suchas a piezoelectric crystal which causes the wire to vibratelongitudinally at ultrasonic frequencies. In these instances, theultrasonic energy is transferred to the medium surrounding the vibratingelement and is used to cause cavitation at the tip of the catheter,which cavitation may cause the disruption of the blockage.Alternatively, an ultrasonic transducer may be placed at the tip of thecatheter to emit ultrasonic waves laterally therefrom and receivereflections from the walls of the surrounding vessel thereby providingan ultrasonic image of the vessel wall. The use of ultrasonicfrequencies produces heat, both along the wall of the catheter and atthe tip which requires a cooling fluid. In addition, titanium must beused in order to prevent fracture of the wire.

In the present invention, the entire catheter 10 is coupled to a sourceof vibrational energy 16 driven by an oscillator 15 operating in therange of 2 to 1000 oscillations per second. These low frequencyvibrations transmit along the catheter to its distal tip 12 providing amechanical motion of the tip. Such mechanical motion can be used to mixa lysing agent with a blockage near the distal tip. The vibrating agent16 (FIG. 1) is inserted into the proximal end of the motion catheter 10as shown in greater detail in FIG. 4. The proximal end 11 of thecatheter 10 matingly engages the oscillating element 16. The oscillatingelement 16 reciprocates in the direction of the long axis of thecatheter 10. Alternatively, the oscillating element 16 may rotateto-and-fro causing a back and forth rotary motion along the wall of thecatheter which is translated to the tip. Or a to-and-fro motion may beused in combination with a back and forth translational motion to effecta wobbling motion at the tip. The use of such motion in combination withthe dispensing of a medicament such as a lysing agent at the tip of thecatheter is illustrated in FIGS. 5 through 10.

In FIG. 5, the distal tip 12 of catheter 10 is shown advanced into ablood vessel 55. The blood vessel inner wall 55 is surrounded by tissuegenerally indicated by 57. An obstruction 51 in the vessel is penetratedby the distal treatment tip 12 of the catheter 10. Once tip 12 of thecatheter 10 is within the obstruction 51 (such as a blood clot) a lysingagent 53 is dispensed from the holes 58 near the tip of the catheter bymeans of pumping the lysing agent 53 from a reservoir (not shown)through the lysing agent lumen 21. At the same time, the mechanicalmotion of the tip, generally indicated at 54, is induced in the distaltip of the catheter by means the vibrating element 16. The combinationof lysing agent 53 emanating from holes 58 in the distal tip 12 of thecatheter 10 in combination with the vibratory motion 54 of the distaltip of the catheter assists in the penetration of the lysing agent intothe obstruction 51, and provides an advantage over prior art.

Alternatively, the distal tip 12 of the catheter 10 may be inserted intothe blockage 51 and passed completely therethrough, as shown in FIG. 6,so that the very distal-most portion of the distal tip 12 extends beyondthe obstruction 51. In such an event, motional waves 54 may be used incombination with the release of a lysing agent 53 from holes 58 in thedistal tip to facilitate dissolution of the blockage 51. This may beparticularly advantageous in the event that plaque 56 is covering aportion of the wall 55 of the vessel.

As shown in FIG. 7, it is also possible to have a plurality of holes 58dispensing the lysing agent 53, both distal to the obstruction 51 andinterior to the obstruction. Such a combination of vibrational motionand spraying of lysing agent into the blockage facilitates the rapiddisruption of the blockage 51.

In FIG. 8, the distal tip 12 is advanced until it is in juxtapositionwith the proximal end of the blockage 51. When the distal tip is inposition, the vibrational waves 54 in combination with the release orspraying of lysing agent 53 affect the dissolution of the blockage 51.

Up until now, we've been referring primarily to vibrational motion inthe tip of the catheter that is axial oscillatory motion generally inthe direction of the axis of the catheter. FIG. 9 shows a rotary motionwhich may be imparted to the tip of the catheter by applying anoscillating rotary motion to the proximal end of the catheter. Thearrows in FIG. 9 show the rotation of various elements of the tip of thecatheter with respect to adjacent elements of the catheter. The catheter10 is a flexible structure and these rotational waves can travel downthe catheter changing direction. Such rotary motion, particularly whenthe tip 12 is embedded within the blockage 51, may be particularlyadvantageous for facilitating the penetration of lysing agent 53 sprayedfrom the holes 58 in the distal tip 12 of the catheter 10. Therotational arrows are generally indicated at 58.

FIG. 10 shows a translational motion which can be used in combinationwith the rotary motion of FIG. 9, which combination of motions may causethe tip 12 of the catheter 10 to “wobble” or “wiggle” causing mixing andenabling the lysing agent 53 to more rapidly permeate the obstruction 51facilitating dissolution thereof.

During the dissolution process, fragments of the obstructing thrombusmay break loose and obstruct the vascular system at once or more pointsremote from the original obstruction. A second preferred embodiment ofthe catheter of the present invention which is especially designed toprevent the dissemination of such fragments to other points in thevascular system is shown in FIG. 11. In this second preferred embodimentthe catheter 10 has a coaxial inflatable member 59 on the outer surfacethereof between the holes 58, through which holes lysing agent (notshown) is sprayed, and the distal tip 12 of the catheter 10. A perfusionchannel (not shown) housed within the body portion of the catheter 10 iscoextensive with the portion of the catheter between fenestrations 60and 61 in the outer wall of the catheter 10 providing fluidcommunication therebetween. Blood enters the perfusion channel (notshown) through the proximal fenestration 60 in the direction indicatedby arrow 60(a). Any fragments of thrombus entrained in the blood as theblood enters the proximal fenestration 60 will pass into the catheterperfusion channel. A particle filter (not shown) is deployed within theperfusion channel to remove such fragments before the blood exits theperfusion channel through the distal fenestration 61 as indicated byarrow 61(a). The filter (not shown) is in-line with the perfusionchannel connecting fenestrations 60 and 61 and can be a polymeric ormetallic mesh or “birds nest” or a filter of the type used to remove fatcells from an aspirate described in U.S. Pat. No. 4,834,703 to Dubrul,et al., (incorporated herein by reference). Such a filter must bein-line with the perfusion channel and coextensive with at least aportion thereof to effectively remove fragments of thrombus and anyother unwanted particulate debris from the perfusate 60(a) and 61(a).

EXAMPLE

To prove evaluate the effectiveness of the present invention, an invitro experiment was performed to evaluate the advantage, if any, ofusing the motion catheter to disburse clots rather than existingtechnology. Blood clots were created in a test tube. The weight of eachclot was measured prior to experimentation. The clots were then treatedwith urokinase at a rate of 5000 IU/ml for 5 minutes to a total of15,000 IU. The clot (thrombus) weights were measured initially andfinally to determine the amount of lysing that had taken place. One ofthe groups (Group 1) was used as a control. Nothing was done to theGroup 1 thrombi except initial and final weighing. Another group (Group2) was treated with the same amount of lysing agent, but the lysingagent was dispersed through the motion catheter while the catheter wasbeing very slowly vibrated, the catheter was placed proximal to the clotin similar fashion as was the aforementioned group. In Group 3, themotion catheter was placed in the clot as in Groups 1 and 2, but theurokinase was pulsed into the clot and no motion was applied to thesystem. In Group 4, the lysing agent was pulsed into the clot as inGroup 36, but a slow (low frequency) vibratory motion was applied to themotion catheter Group 5 clots were treated with saline and slowvibration. In Groups 2, 4, and 5 (Groups with a motion applied to themotion catheter) the amount of lysing of the clot/thrombus was greatlyincreased as determined by the difference in weight of the clot/thrombusbefore and after the one hour treatment. Those results are tabulated inTable 1 where the percentage of lysing is the difference between theinitial and final weight of the clots divided by the initial weight, thequotient multiplied ×100.

TABLE 1 Group 1 4.5% Lysing Group 2 68% Group 3 26% Group 4 45% Group 545%

From the foregoing data it is clear that low frequency vibration withadministration of a lysing agent (Group 2) give the best results.Surprisingly, the Group 5 clots (no lysing agent) that were subjectedonly to a low frequency (1-1000 Hz) vibrating member in the presence ofsaline exhibited substantial dissociation under the conditions of theexperiment. This suggests that the introduction of a simpleintravascular wire or similar elongate member vibrating at lowerfrequencies (<1000 Hz) into a blocked vessel may be useful fordisrupting clots.

The invention will now be described with respect to FIGS. 12 through 15.An aspiration device generally indicated by the numeral 100, is shownwith respect to FIG. 12. The aspiration device 100 includes a suctionmechanism 102 located at the proximal end 11 of the motion catheter 10.The aspiration device 100 additionally includes an outer sleeve 104, asshown more clearly in FIG. 13. The outer sleeve extends from theproximal end 11 to the distal end 12 of the device 10.

During, after, or before the obliteration of the atheroma or otherobstruction in the blood vessel, small particles represented byfragments 106 exist within the blood vessel. As is well known, thesefragments can cause extreme health difficulties such as stroke,ischemia, collateral vessel blockage and the like. It is thus,advantageous to remove such particles 106 from the blood vessel. Theaspiration device 100, which activated, causes a suctioning, or lowpressure, to be developed at the proximal end drawing blood in adirection of the arrows 108. The aspiration device is activated by thesuction mechanism 102. The suction mechanism 102 includes a chamber 110and a plunger 112. When the plunger 112 is pulled away from the chamber110, a low pressure area or vacuum is created in a lumen of the catheter10. As noted below, this causes the blood flow to proceed from thedistal end to the proximal end. Other vacuum sources such as amechanical pump, or an electromechanical pump, may also be used as thesuctioning mechanism 102, to create the low pressure area.

It will also be appreciated that, while it is not shown in FIG. 12, athird port could be added comprising an injection port. The injectionport, while not shown here, is shown in the earlier filed drawingsconnected with this matter, specifically FIG. 1 of U.S. Pat. Nos.5,498,236 and 5,380,273. Additionally, the motion catheter 10 mayinclude distal end 12 having an infusion port such as infusion port 61,as described with reference to FIG. 11 of the above identified patents.

It will be appreciated that the injection port and the aspiration portmay be activated independently and simultaneously. Thus, while fluid maybe moved up and through the catheter from the distal end to the proximalend, it may also be appreciated that fluid may also be moved down andthrough the proximal end 11 through the distal end 12 using theinjection port. In this way, while simultaneously aspirating, a fluidsuch as a medicament, for example saline or sterile water, may beinjected into the patient's blood vessel simultaneously with theaspiration process. Additionally, it will be appreciated that fluid ofany kind can be moved in either direction through the catheter usingaspiration and infusion including fluid such as a contrast fluid.

It will be appreciated that FIG. 11 of the above identified patents,noted particularly at U.S. Pat. No. 5,498,236, col. 6, lines 50 through57, and at col. 6, line 65 through col. 7, line 12 and U.S. Pat. No.5,380,273, col. 6, line 58 through col. 7, line 25, specificallydisclose polymeric, metallic mesh, or birds nest filter described withrespect to aspiration and the like. A filter such as the one describedabove, or filter cartridge as specifically referred to in U.S. Pat. No.4,834,703, may be inserted within the outer sleeve 104 coaxially withthe catheter. The filter cartridge, or filter, traps the particulatematter or particles 106, thereby removing the same from the blood vesseland consequently from the blood stream.

As shown in FIGS. 12 and 13, the motion catheter 10 may be activatedduring aspiration. It may be desirable to remove particulate matter 106as the tip is in motion to either vibration or rotation. Alternatively,the aspiration device 100 may be activated both after and beforeactivation of the motion catheter.

With respect to FIG. 14, there is shown another embodiment of theaspiration device 100, wherein the distal end 12 of the motion catheter10 includes the distal end having fenestrations. In this embodiment, thein-line polymeric filter and/or filter cartridge would be insertedwithin the motion catheter itself to trap the particulate matter 106.The fenestrations 114 are shown in FIG. 14 as being generallyrectangular in shape. It will be appreciated that a variety of shapes,sizes, and styles may be appropriate depending upon the particularfunction, blood flow, and level of force of the aspiration device 100.Similarly to the previously discussed embodiment shown in FIG. 13, theembodiment shown in FIG. 14 having fenestrations 114, allow theparticulate matter to enter the fenestrations as a result of the lowpressure being created by the activation of the aspiration device 100,and thereby removed by the blood stream through the in-line polymericfilters as discussed above.

With respect to FIG. 15, there is shown a third embodiment of theaspiration device 100 in accordance with this invention. In theaspiration device of FIG. 15, the outer sleeve 104 includes an occludingmechanism 116 which prevents blood from preceding around the occludingmechanism 116 and causes blood flow to enter the proximal end of theouter sleeve 104. Similar to the previously discussed embodiments ofFIGS. 13 and 14, the occluding mechanism 116 operates to force bloodflow to an area where an in-line polymeric filter or filter cartridgemay trap the particulate matter 106, thereby removing it from the bloodvessel and consequently the blood stream.

It will be appreciated that a variety of other filters not describedherein may be used. For example, the filters may comprise a variety ofdifferent shapes and sizes and may be located in slightly differentpositions on the catheter.

The occluding mechanism 116 comprises an exemplary embodiment, anangioplasty type balloon which is selectively inflated to cause ablockage in the blood vessel as shown clearly in FIG. 15. Otheroccluding mechanisms of course are within the scope and spirit of thisinvention.

Also, it will be appreciated that an occlusion balloon, or centeringballoon, may also be used in place of the angioplasty type balloon. Theocclusion or centering balloon is distinguished from the angioplastyballoon because it does not inflate to a predetermined sized. Rather theocclusion balloon continues to increase in size the more it is inflated.Also, the occlusion balloon conforms itself to the shape and size of theinner vessel wall. In some instances, it may well be preferable to usethe occlusion balloon as opposed to the angioplasty type balloon. Itwill be understood herein that when referring to the angioplasty balloonbelow, that other types of balloons including the occlusion or centeringballoon, may well be substituted in its place.

Similarly with respect to FIGS. 13 and 14, the aspiration device of FIG.15 may be used before, after, or during activation of the motioncatheter 10.

With respect to FIG. 16, there is shown another embodiment of the motioncatheter 10 in accordance with this invention. In this embodiment, themotion catheter 10 includes an angioplasty-type balloon 118 at thedistal end 12. The angioplasty-type balloon 118 is formed, as isconventional in the field and more particularly as shown and describedin U.S. Pat. Nos. 4,922,905, 4,838,268, 4,808,164, and 4,707,670, whichare specifically incorporated herein by reference, and represents atypical angioplasty-type balloon. As noted above, an occlusion balloonsuch as those identified in U.S. Pat. Nos. 5,637,086, 5,222,970,5,074,869, and 4,130,119, which are also specifically incorporatedherein by reference, may be substituted for the angioplasty-typeballoon.

In the embodiment shown in FIG. 16 showing the angioplasty balloon 118,the motion catheter may be activated before, during, or after, balloonexpansion. It is believed that such motion of the angioplasty balloon isparticularly useful in relieving the blood vessel obstruction. It willbe appreciated that the various elements, shown in FIGS. 12 through 15,may be combined or used alternatively with the embodiment shown in FIG.16 within the spirit and scope of this invention. However, it is notnecessary for the beneficial effects and advantages of the embodimentshown in FIG. 16 to provide the alternative structures shown anddescribed in such combinations.

With respect to FIGS. 17 through 20, there is shown an alternateembodiment of the motion catheter device 10 having a coaxially filtertrap 120. As similarly shown with respect to the '273 and '236 patentsdescribed above, the filter trap 120 is deployable and expandable asshown in FIGS. 17 through 20.

In FIG. 17 the filter trap is in its initial stage of deployment. InFIG. 18 the filter trap has been fully expanded. Additionally, in FIG.18 there is shown the filter trap 120 used in combination with theoccluding mechanism 116. Using a combination of these devices providesthe invention with the ability to trap particulate matter 106, whetherit flowed against or with the arrows 108. It will be readily appreciatedthat any particulate matter traveling in the direction opposite of thearrows would be trapped within the filter trap 120. The filter trap 120is made of polymeric mesh and can be expanded to a variety of shapes andsizes. The device 10 (not shown) includes activation mechanism (notshown) which can readily expand or contract the filter trap 120.

It will be appreciated that the inflatable coaxial structure describedwith respect to the '273 and '236 patents can, in fact, define a filtersuch as the ones described above. It will also be appreciated that acombination of the inventions taught by the '236 and '273 patents andthe disclosure herein can be combined. In fact, an occluding elementcould be distal to the distal end of the catheter 12 with a filter beingin-line in an aspiration device. In this way, the particulate matter isprevented from flowing down stream by the occlusion mechanism while theaspiration device is activated causing the particulate matter to bedrawn back into the inflatable coaxial filters. Thus, the fluid downstream of the occluding mechanism would be relatively free ofparticulate matter while the particulate matter would be substantiallytrapped within the coaxial filter.

Upon activation of the motion catheter, a spinning vortex is created.Upon the direction of the user, the particulate matter 106 can bedirected, either proximally or distally, to be trapped by the filtersystem described above. Again, the object of trapping particulate matteris accomplished. In this way, the spinning vortex causes additional andfurther particulate matter to be trapped in a coaxial filter.

Additionally, polymeric shapes such as a frusto-conical shape filtertrap alternative embodiment generally indicated by the numeral 122, mayalternatively be employed. The filter trap 122, shown in cross sectionFIG. 19, includes an otter member 124 and an inner member 126. Bothmembers are connect to a shaft 128. Upon activation both inner and outermembers, 124 and 126 respectively, are deployed or expanded within theblood vessel. Upon deactivation, both members are contracted and fitsnugly along shaft 128. The duel filter has the purpose of (1) sealingagainst the vessel wall, (2) capturing large and small particles and theprevention of dissemination of such fragments, (3) the centering of thecatheter during motion, (4) capturing and holding particulate matter fordissolution, and (5) capturing of particulate matter allowing blood orsmaller particles to flow through, whereby, at the end of the procedure,the filter trap is un-deployed and particulate matter is removed.

The filter shaft system, upon trapping the particulate matter 106, caneither remain deployed until the blood flow causes the particulatematter 106 to be dissolved or can be contracted and then removing thedevice 10 from the blood vessel and then removing the trappedparticulate matter 106 will thus remove the particular matter from theblood system.

The aforesaid specification taken in connection with the drawings andthe aforementioned experiment sets forth the preferred embodiments ofthe present invention. The embodiments of the invention disclosed hereinare the best modes contemplated by the inventors for carrying out theirinvention in a commercial environment, although it should be understoodthat various modification can be accomplished within the scope of theinvention.

What is claimed is:
 1. A device for insertion into a body lumen useful for dissolution of obstructive material, the device comprising: a source of mechanical motion; an elongated member having a proximal end, a distal portion, and a longitudinal axis therebetween, wherein the proximal end is matingly engageable with the source of mechanical motion; and an expandable member axially offset from the distal portion of said elongate member wherein at least the distal portion of said elongate member is caused to vibrate by said source of mechanical motion, enabling said elongate member to mix or dissolve said obstructive material while said expandable member inhibits movement of the obstructive material along the body lumen.
 2. A device of claim 1, the body lumen comprising a blood vessel, wherein said elongated member is introduceable into the blood vessel.
 3. A device of claim 1, wherein said source of mechanical motion is adapted to mix or otherwise dissolve a blood clot.
 4. A device of claim 1, wherein said elongate member includes at least one port located at the proximal end of said elongate member.
 5. A device of claim 4, wherein said port is adapted to deliver a diagnostic or therapeutic agent.
 6. A device of claim 4, wherein said at least one port is and is in fluid communication with openings at the distal portion of said elongate member for the infusion of fluid therethrough.
 7. A device of claim 1, wherein said elongate member comprises a wire.
 8. A device of claim 1, wherein said source of mechanical motion delivers at least one motion selected from a group consisting of rotational motion and translational motion.
 9. The device of claim 8, wherein motion delivered by the source of motion comprises rotational and translational motion.
 10. A device of claim 1, wherein said expandable member comprises a balloon.
 11. The device of claim 1, wherein the expandable member is disposed distally of the distal portion.
 12. The device of claim 1, wherein the expandable member is disposed proximally of the distal portion.
 13. The device of claim 1, further comprising a tubular body extending along the axis, the expandable member being carried by the tubular member.
 14. The device of claim 1, further comprising first and second expandable members, the distal portion being disposed therebetween.
 15. The device of claim 1, wherein the source of mechanical motion effects vibration of the distal portion at a frequency of less than 1000 Hz.
 16. The device of claim 1, wherein the distal portion has a surface, and wherein the outer surface is moved by the source of mechanical motion and is radially exposed to the surrounding body lumen so that movement of the outer surface effects mixing of fluid in contact with the occlusive material.
 17. A device for insertion into a body lumen useful for dissolution of obstructive material, the device comprising: a source of mechanical motion; and an elongated member having a proximal end, a distal end, and a longitudinal axis therebetween, wherein the proximal end is matingly engageable with the source of mechanical motion, wherein at least the distal end of said elongate member is caused to vibrate by said source of mechanical motion at a frequency below 1,000 Hertz, enabling said elongate member to mix or otherwise dissolve said obstructive material.
 18. A device for insertion into a body lumen useful for dissolution of obstructive material, the device comprising: a source of rotational and/or translational mechanical motion having a frequency below 1,000 Hertz; and an elongated member having a proximal end, a distal end, and a longitudinal axis therebetween, wherein the proximal end is matingly engageable with the source of mechanical motion, wherein at least the distal end of said elongate member is caused to vibrate by said source of mechanical motion, enabling said elongate member to mix or otherwise dissolve said obstructive material. 